634 F.

2d 106

PHARMACEUTICAL MANUFACTURERS ASSOCIATION,

a Delaware
nonprofit membership
association, Plaintiff, American College of Obstetricians &
Gynecologists; National Association of Chain Drug Stores,
Inc.; American Society of Internal Medicine; Private Medical
Care Foundation, Inc.; Congress of County Medical Societies,
Inc.; The Pottawatomie County Medical Society, Inc.; The
Oklahoma State Medical Association; Francis A. Davis, M.D.,
Intervening Party Plaintiffs,
v.
FOOD AND DRUG ADMINISTRATION, Joseph A. Califano,
Sec. of
HEW, Donald Kennedy, Comm. of Foods and Drugs,
Defendants,
Consumers Union of U. S., Inc., Consumer Federation of
America, National Women's Health Network, Women's
Equity Action League, Intervening Party Defendants,
National Association of Chain Drug Stores, Inc., Plaintiff
Intervenor, Appellant.
No. 80-1455.

United States Court of Appeals,

Third Circuit.
Argued Oct. 16, 1980.
Decided Nov. 5, 1980.

Joel E. Hoffman (argued), Anthony L. Young, Gloria C. Phares, Wald,

Harkrader & Ross, Washington, D. C., Richard L. Sutton, Morris,
Nichols, Arsht & Tunnell, Wilmington, Del., Thomas D. Quinn, Jr.,
Reasoner, Davis & Vinson, Washington, D. C., for National Ass'n of
Chain Drug Stores, Inc.

Nancy C. Garrison (argued), Barry Grossman, Sanford M. Litvack,

Washington, D. C., Nancy L. Buc, Michael P. Peskoe, Rockville, Md.,
Peggy L. Ableman, Wilmington, Del., for Food & Drug Administration,
et al.
Marcia D. Greenberger, Washington, D. C., (argued), Nancy Duff
Campbell, Women's Rights Project Center for Law and Social Policy,
Washington, D. C.
Aida Waserstein, Bader, Dorsey & Kreshtoll, Wilmington, D. C., for
Consumers Union of U. S., Inc., et al.
Before HUNTER and WEIS, Circuit Judges, and CAHN,* District Judge.
OPINION OF THE COURT
PER CURIAM:

In this appeal, the National Association of Chain Drug Stores, Inc. challenges
the Food and Drug Administration's authority to promulgate 21 C.F.R.
310.515 (1980).1 The challenged regulation requires that patient package insert
be provided to every patient receiving certain estrogen drugs. In a thorough and
well-reasoned opinion, Judge Stapleton, of the District of Delaware, set forth
the statutory grounds for the FDA's regulation.2 We affirm the judgment of the
district court.

Responding to the recent studies linking postmenopausal use of estrogens with

endometrial cancer,3 the FDA conducted hearings and published the estrogen
regulation. Although the FDA has broad statutory authority to protect the public
health by "(making) ... such rules and regulations as may be necessary to carry
out the provisions of (The Federal Food, Drug and Cosmetic Act of 1938, 21
U.S.C. 301 et seq. (1976))," 4 the FDA must exercise that power pursuant to a
Congressional objective expressed elsewhere in the Act. Mourning v. Family
Publications Services, Inc., 411 U.S. 356, 369, 93 S.Ct. 1652, 1660, 36 L.Ed.2d
318 (1973).

In the instant case, the district court found, and this Court affirms, that the
Agency promulgated the challenged regulation in order to effectuate the
objectives reflected in Section 502(a) of the Act, 21 U.S.C. 352(a) (1976).
Section 502(a) authorizes the Agency to act if it finds a drug's labeling to be
false or misleading, as those terms are defined in Section 201, 21 U.S.C. 321
(1976) of the Act. The FDA found that, without the patient package insert, the

estrogen labeling was "misleading" because it failed to reveal facts "with

respect to consequences which may result from the use of the article to ... under
the conditions of use prescribed in the labeling ... or under such conditions of
use as are customary or usual." 21 U.S.C. 321. On its face, therefore, the Act
authorizes the Agency's actions.
4

We reject appellant's argument that the legislative history of the 1938 Act, read
in conjunction with the Durham-Humphrey Amendments to the Act in 1951
(Section 503(b)(2), 21 U.S.C. 353(b)(2) (1976)), requires a contrary decision.
Section 503(b)(2) exempted prescription drugs from some labeling
requirements but not from those presently in issue. The Senate Report states:

Paragraph (2) of the new subsection (b) provides that a drug dispensed on
prescription shall be exempt from the provisions of the act relating to
misbranding of drugs except those which specify that a drug shall be deemed to
be misbranded if its labeling is false or misleading in any particular (Sec.
502(a)) ... These provisions continue to apply to any drug subject to the act,
whether sold over-the-counter or on prescription.

(emphasis added). S.Rep.No.946, 82d Cong., 1st Sess. 9-10 (1951), reprinted in
(1951) U.S.Code Cong. & Ad.Serv., pp. 2454, 2462. Thus, while Congress
closed the door on one statutory ground for FDA supervision of the labeling of
prescription drugs, it appears to have left open Section 502(a) as a separate
passageway through which the FDA may require patient package inserts.

Accordingly, the district court's judgment will be affirmed.

Hon. Edward N. Cahn, United States District Court Judge for the Eastern
District of Pennsylvania, sitting by designation

21 C.F.R. 310.515 (1980) provides:

(a) The Commissioner of Food and Drugs concludes that the safe and effective
use of drug products containing estrogens requires that patients be fully
informed of the benefits and risks involved in the use of these drugs.
Accordingly, except as provided in paragraph (e) of this section, each estrogen
drug product restricted to prescription distribution, ... shall be dispensed to
patients with labeling in lay language containing information concerning
effectiveness, contraindications, warnings, precautions, and adverse reactions.
The patient labeling shall be provided as a separate printed leaflet independent

of any additional materials.

(b) The patient labeling shall specifically include the following:
(1) Name of the drug.
(2) Name and place of business of the manufacturer, packer, or distributor.
(3) A statement regarding the proper use of estrogens, particularly short-term
use in moderate to severe vasomotor symptoms of the menopause and
prevention of breast engorgement. It is to be stated that estrogens are not
indicated for certain conditions, i. e., nervousness, preservation of supple skin,
or maintenance of a youthful feeling. The limited usefulness in preventing
breast engorgement is also to be noted.
(4) A warning regarding the most serious dangers of estrogens and the relative
risk in users versus nonusers, where known, including:
(i) Endometrial carcinoma. The importance of minimizing dose and duration of
use is to be stressed, as is the importance of using estrogens only when
necessary. A statement indicating that women who have had total
hysterectomies have no risk of endometrial carcinoma.
(d)(1) Patient labeling for each estrogen drug product shall be provided in or
with each package of the drug product intended to be dispensed or administered
to the patient. However, patient labeling for drug products dispensed in acute
care hospitals or long-term-care facilities will be considered to have been
provided in accordance with this section if provided to the patient prior to
administratrion (sic) of the first dose of estrogen and every 30 days thereafter,
as long as the therapy continues.
(2) In the case of estrogen drug products in bulk packages intended for multiple
dispensing, and in the case of injectables in multiple-dose vials, a sufficient
number of patient labeling pieces shall be included in or with each package to
assure that one piece can be included with each package or dose dispensed or
administered to every patient. Each bulk package shall be labeled with
instructions to the dispensor to include one patient labeling piece with each
package dispensed or, in the case of injectables, with each dose administered to
the patient....
(3) Any estrogen drug product restricted to prescription distribution, except as
noted in paragraph (e) of this section, that is not labeled as required by this
section and that is either introduced or delivered for introduction into interstate
commerce, or held for sale after shipment in interstate commerce is misbranded

pursuant to section 502 of the act. However, an estrogen drug product in the
possession of a wholesaler or retailer before the effective date of this section is
not misbranded if adequate numbers of copies of the patient labeling are
furnished to the wholesaler or retailer to permit any retail purchaser after the
effective date to obtain such labeling with the product. The requirement that
any estrogen drug product be dispensed with patient labeling, as applied to
physicians who dispense or administer the drug, will not be effective for
supplies in their possession on the effective date, but will apply only to supplies
received thereafter.
(f) The Food and Drug Administration has available patient labeling for
estrogens that includes information responsive to all items specified in
paragraph (b) of this section. The labeling has been published in the FEDERAL
REGISTER as part of DESI notice, and updated versions will continue to be
published as guides as changes occur. Any person may rely on the latest
published version of this labeling as complying with paragraph (b) of this
section.
2

Pharmaceutical Mfrs. v. Food & Drug Admin., 484 F.Supp. 1179 (1980)

See generally 41 Fed.Reg. 43,108 (1976) (Proposed rule)

United States v. Nova Scotia Food Products, 568 F.2d 240, 246 (2d Cir. 1977),
quoting Mourning v. Family Publications Services, Inc., 411 U.S. 356, 369, 93
S.Ct. 1652, 1660, 36 L.Ed.2d 318 (1973)